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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantBD DIAGNOSTIC SYSTEMS
PMA NumberP970018
Supplement NumberS016
Date Received06/09/2009
Decision Date07/02/2009
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the method of manufacturing from a manual process to an automated process to reduce production costs and improve control of the manufacturing process.
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